FDA Advisory Committee Recommends Approval of Cologuard

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Exact Sciences has announced the FDA Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee unanimously voted to approve its stool-based DNA colorectal cancer screening test Cologuard.

In a 90-site trial of the test, Cologuard was found to detect 92.3 percent of colorectal cancer in average risk patients.

The FDA is not obligated to follow the advisory committee's recommendation, but will consider its guidance as Cologuard is evaluated.

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